Vascular suturing device

ABSTRACT

A surgical device for suturing vascular vessels is described, as well as methods for suturing tissue employing the surgical device. The device includes a distal member for insertion into a vascular vessel puncture wound. The distal member contains a suture and needle engaging fitting. At least one needle is advanced through tissue adjacent the puncture wound and into the needle engaging fitting to draw lengths of suture material which can then be used to close the puncture wound.

BACKGROUND OF THE INVENTION

The present invention generally relates to surgical instruments andmethods of suturing tissue.

A number of diagnostic and treatment procedures are conductedintravascularly. Typically, a catheter is introduced into the vascularsystem at a convenient access location and is then guided to the targettreatment site. The Seldinger Technique is one of the well-known earlyexamples of this type of procedure which can include catheterization andangioplasty techniques. Procedures such as this require a vascularaccess. Typically an introducer sheath with or without a guide wire isinserted through a puncture wound in a vessel such as the femoral arteryat a location near the groin. A catheter and other instrumentation canthen be inserted through the sheath and guided to the targeted treatmentsite. After the diagnostic and/or treatment procedure has beencompleted, the puncture wound must be closed. Closing the wound can bedifficult because of the substantial bleeding that can occur through anopen wound in the vascular vessel. One technique for hemostasis includesapplying pressure near or upstream of the puncture site. This approachsuffers from many deleterious effects, not the least of which are thatit can be time consuming and extremely uncomfortable—even painful—forthe patient because the pressure is applied directly on or adjacent tothe traumatized site. Frequently anticoagulants are employed for theoriginal diagnostic/treatment procedures. This delays clot formationduring the procedure, and this effect lasts through the initial recoveryperiod, lengthening the time during which pressure must be applied tothe wound for up to twelve hours or more. During this initial recoveryperiod, it is imperative that the patient remain still, further addingto the patient's discomfort.

Alternatively, the puncture wound can be closed with sutures. This canbe extremely difficult because the vascular vessel with the puncturelies underneath the patient's outer skin. Some vascular vessels, notablythe femoral artery, appear to be relatively large; however, in practice,even the largest arteries cannot be readily sutured. Therefore, deviceshave been developed to facilitate subcutaneous suturing of arteries andveins. These devices can extend through the outer tissue to the puncturewound in the vascular vessel. Needles are then deployed from the deviceto suture the tissue adjacent the puncture wound.

Certain devices are inserted subcutaneously into the puncture wound. Oneor more needles are deployed to pierce the tissue in a direction fromthe exterior to the interior of the vascular vessel. The needlescontinue to be advanced into a depository in the portion of the devicelocated within the lumen of the vessel. The suturing device can beremoved from the vessel (and the patient) by withdrawing the needles andsuture material at the same time. These devices leave an inverted suturepath after completion of the closure. The suture material runs from theexterior tissue surrounding the puncture wound back up through the wounditself which is then tied off. Some complications may arise resultingfrom this type of closure, including oozing, excessive bleeding, and, onrare occasions, knot loosening. It would be preferred to provide asuturing device that allows the suture path to extend across thepuncture opening internal of the vessel membrane with the suture knotoverlying the exterior of the closed wound.

In view of the above background, there remains a need for improvedand/or alternative methods and devices for closing the vascular openingor punctures. The present invention is addressed to these needs.

SUMMARY OF THE INVENTION

The present invention relates to suturing devices and the use thereof.Various aspects of the invention are novel, nonobvious, and providevarious advantages. While the actual nature of the invention coveredherein can only be determined with reference to the claims appendedhereto, certain forms and features, which are characteristic of thepreferred embodiments disclosed herein, are described briefly asfollows.

In one form, the present invention provides a suturing device forsuturing an opening in a vascular vessel. The device comprises aproximal member that can be configured as an elongate body with a needlechannel extending at least partway therethrough and sized to receive atleast one needle; a distal member configured to be inserted within alumen of a vascular vessel, where the distal member has a receptaclelocated therein and a length of suture material with a needle engagingfitting positioned in the receptacle; and an intermediate memberdisposed between the proximal member and the distal member. In oneembodiment, the intermediate member defines a tissue receiving area andhas a first opening providing a passageway to the channel and a secondopening providing a passageway into the receptacle. In otherembodiments, the distal member defines a substantially linearlongitudinal axis and the intermediate member can deviate from thatlongitudinal axis. In other embodiments, the intermediate defines atissue receiving area that provides a linear needle pathway through thetissue receiving area.

In another form, the present invention provides a suturing device forsuturing an opening in a vascular vessel. The suturing device comprises:a proximal member including an elongate body having a needle channeltherethrough sized to receive at least one needle and including a needlecartridge slidably mounted thereon configured to contain two or moreneedles; a distal member configured to be inserted within a lumen of avascular vessel and having a receptacle located therein and a length ofsuture material with a needle engaging fitting positioned in thereceptacle; an intermediate member disposed between the proximal memberand the distal member, where the intermediate member defines a tissuereceiving area and has a first opening providing a passageway to thechannel and a second opening providing a passageway into the receptacle.and a length of suture material comprising a needle engaging fittingpositioned in the receptacle to engage a needle entering from the secondopening.

In yet another form, the present invention provides A method of suturingan opening in a vascular vessel, said method comprising: inserting avascular suturing device through the opening in the vascular vessel,said suturing device comprising a proximal member having a needlechannel and a needle therein; a distal member configured to be insertedinto the lumen of the vascular vessel, the distal member having a cavitytherein and a length of suture material disposed in the cavity; and aconnecting member between the proximal and distal members, theconnecting member angled or curved to offset the channel and the cavityfrom the opening in the vascular vessel and having a first opening intothe needle channel and a second opening into the cavity; sufficientlyadvancing the needle through the needle channel to pierce a portion oftissue adjacent the opening in the vessel and extend into the cavity ofthe distal member; and capturing the suture within the cavity with theneedle; and retracting the needle carrying a first portion of the sutureback through the tissue and the channel.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded view of one embodiment of a suturing device inaccordance with the present invention.

FIG. 1A is an illustration of suture material suitable for use in thesuturing device of FIG. 1 accordance with the present invention.

FIG. 2 is a cross-sectional view of the suturing device of FIG. 1including the suture material of FIG. 1A.

FIG. 3 is a perspective view of a ferrule and a needle for use with thesuturing device in accordance with the present invention.

FIG. 4 is a cross-sectional view of the ferrule engaged with the needleof FIG. 3.

FIG. 5 is an enlarged, cross-sectional view of the intermediate memberof the suturing device of FIG. 1 with the suture material of FIG. 1A.

FIG. 6 is a radial cross-sectional view taken along section line 6-6 ofthe intermediate member illustrated in FIG. 5.

FIG. 7 is an enlarged cross-sectional view of an alternative embodimentof a connector member with suture material and two laterally disposedferrules in accordance with the present invention.

FIG. 8 is a perspective view of an alternative embodiment of a suturingdevice with a needle cartridge for use in accordance with the presentinvention.

FIGS. 9-16 illustrate the use of the suturing device of FIG. 1 to suturevascular tissue.

FIG. 17 is a perspective view of a hollow needle for use in the suturingdevices described herein.

FIGS. 18-20 illustrate the use of the suturing device of FIG. 1 with ahollow needle of FIG. 17.

FIG. 21 is a perspective view of one embodiment of a suture securingdevice for use in the present invention.

FIG. 22 is a perspective view of an alterative embodiment of a suturesecuring device for use in the present invention.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 is an exploded view of one embodiment of a suturing device 10 forsuturing vascular vessels in accordance with the present invention.Device 10 includes a proximal member 12, a distal member 14, and anintermediate member 16 located therebetween. Device 10 includes one ormore needles 18 advanceable through a portion of the proximal and distalmembers. A needle pusher 26 can either push or engage needle 18 toadvance it through a channel 24 in the proximal member and throughvascular tissue adjacent the puncture wound. In one form, suturematerial can be attached to needle 18 which is then advanced in a distaldirection through tissue. In other forms, suture material can be locatedwithin distal member to be snared by a needle to be withdrawn in aproximal direction through tissue. A second needle and subsequentneedles can be similarly configured and manipulated to place suturesthrough tissue adjacent a puncture wound in a vascular vessel. Thesuture material(s) threaded through the vascular tissue can be drawntaut closing the puncture wound. A surgical knot or other suturesecuring device can complete the wound closure.

As used herein, the term “proximal” refers to a direction toward thesurgeon and away from the patient or a location closer to the surgeon,while the term “distal” refers to a direction towards the patient andaway from the surgeon or a location closer to the patient.

Proximal member 12 is provided as an elongated portion with asubstantially cylindrical or oval radial cross section. Member 12includes a first end of sufficient dimensions to be readily grasped bythe surgeon to manipulate the device during the procedures. Proximalmember 12 can also include a gripping portion to facilitate handlingduring the surgical procedure. Needle channel 24 runs longitudinallyalong at least a portion of proximal member. In one embodiment, channel24 extends along the entire length of proximal member from a first endpositioned proximal to the surgeon to a second end adjacent tointermediate member 16. In this embodiment, one or more needle(s) 18 andneedle pusher(s) 26 can be inserted into and retrieved from channel 24at the first end. In other embodiments, channel 24 extends only partlythrough the proximal member 12. Needle channel 24 can be centrallylocated along proximal member 12. In preferred embodiments, proximalmember 12 includes a single needle channel 24 through which one, two,three, or more needles can be advanced. Alleviating multiple needlechannels within the suturing device provides a more compact member,which can be particularly advantageous for subcutaneous procedures.

Channel 24 is sized and dimensioned to allow one or more needles 18 tobe advanceable therethrough and into vascular tissue around the puncturewound. Furthermore, channel 24 can be either partly or completelyencased within the body of proximal member 12. However, in a preferredembodiment, channel 24 is not encased within the body of proximal member12. Rather, channel 24 is provided as a slot formed into the surface ofproximal member 12. Preferably the slot is configured to retain one ormore needles within the slot. For example, the slot can be formed tohave an opening at the exterior surface of proximal member that isnarrower than the diameter of the needles (and optionally the pusher)while the internal portion or diameter of the slot can be dimensioned topermit facile movement of the needle therethrough. An exit opening islocated at the distal end of channel 24.

Proximal member 12 includes a blood return line or lumen 25 thatterminates in a fitting 27, for example, a luer lock that can be matedto a syringe. Alternatively, blood return lumen 25 can terminate in avalve or shunt to control and stop blood flow therethrough. It ispreferable that blood return lumen 25 be transparent to allow visibleobservation of blood originating from inside the vascular vessel. Thiscan facilitate proper placement of the device for suturing.

Distal member 14 is sized and/or configured to be received within anopening or wound leading to a lumen of a patient's vascular vessel.Therefore, it is preferable that at least distal member 14 be formed ofa flexible or elastomeric material that is biocompatible—particularlywith blood. In a preferred embodiment, proximal member 12 and distalmember 14 define a longitudinal axis. In additional embodiments, distalmember 14 can be coated or impregnated with a lubricant, bioactiveagent, such as an anticoagulant material, and the like. In certainembodiments, distal member 14 is composed of a biocompatible polymericmaterial commonly used for catheters, such as silicone rubber,polyolefin polyurethane, polytetrafluoroethylene, and the like.

FIG. 1A illustrates one or more lengths of suture material 20 that canbe included in receptacle 22 of distal member 14 in accordance with oneembodiment of the present invention. The lengths of suture material 20can include one or more fittings 21, 23, for example, a ferrule or cuffof porous or mesh material, to engage the needle.

Distal member 14 includes a receptacle 22. Receptacle 22 is sized toreceive at least one length of suture material 20 with a correspondingfitting 21, as specifically shown in FIG. 2. Preferably receptacle 22 issized to hold one, two, or more separate lengths of suture material.Each length of suture material can include either a single fitting 21 ortwo fittings—one on each end. In a preferred embodiment, receptacle 22is provided as a multi-stage or tapered recess. Each fitting ispositioned within a receptacle to allow for ready deployment andsubsequent engagement with needle 18 advancing from channel 24 inproximal member 12. Preferably the fittings are releasably retained sothat needles advancing into receptacle 22 can sequentially engage thefittings without forcing that fitting distally further or deeper intothe receptacle. In one form, this can include a shoulder or abutment 30extending from the internal wall of receptacle 22 to abut a distal endof a fitting. In other embodiments, this can include configuring theinternal dimensions of receptacle 22 to taper or decrease in diameter inthe distal direction. In other embodiments, a multi-stage receptacle 22or stepped internal walls receptacle 22 can prevent movement of thefittings in the distal direction. In still other embodiments, thefittings are loaded within the receptacle 22 to bear against the suturematerial which is packed within the end of receptacle 22. In thisembodiment, the bulk of suture material in receptacle 22 can inhibit orprevent distal movement of the fittings upon initial engagement withneedle 18.

FIGS. 3 and 4 illustrate a portion of needle 18 and fitting 21 in theform of a ferrule 44. Needle 18 includes a distal tip 32 and a proximalend 34. Distal tip 32 is configured as a tissue piercing point or abarbed tip. Needle 18 is configured to grab suture material located inthe lumen of the vessel and withdraw the suture material throughvascular tissue. In the preferred embodiment, distal tip 32 isconfigured to securely engage with ferrule 44 which, in turn, isattached to a length of suture. Ferrule 44 can be extremely small,having roughly a diameter similar to or slightly larger than that of thesuture material 20. Alternatively, ferrule 44 can have approximately thesame diameter as the diameter of needle shaft 35. In this embodiment,distal tip 32 has a smaller diameter to allow it to be received insideferrule 44. Distal needle tip 32 includes at least one recessedengagement surface or shoulder 37 configured to matingly engage with acorresponding engagement surface 38 provided on or in ferrule 44. In oneform, the engagement surface is a tab extending into the interior offerrule 44. In other embodiments, the engagement surface is a shoulderextending radially inward in ferrule 44 or a groove partly or completelyencircling an interior wall of ferrule 44. Fitting 23 also may be in theform of a ferrule 46 shown in FIGS. 5 and 6. Ferrule 46 may have similarneedle retention features.

FIGS. 5 and 6 show that the ferrules 44 and 46 need not be the samesize—particularly the same diameter. In this regard certain advantagescan be gained by providing the proximally located ferrule 44 with adiameter greater than that of the distally located ferrule 46. Forexample, this will allow sufficient room for the suture materialextending from ferrule 44 to extend along side of ferrule 46—betweenferrule 46 and an internal wall section of receptacle 22. In otherconsiderations, the suture material from the proximally located ferrule44 can be disposed between that ferrule and the next distally locatedferrule 46. Ferrules 44 and 46 can also be tapered or “streamlined” toallow them to be readily pulled through a small needle puncture site intissue as described below.

In one embodiment, the length of suture material which is attached tothe different ferrules on each end can include different color codingsfor the different ends. This allows a surgeon to differentiate whichsutures are attached to which ferrules to facilitate tying suitableknots to close puncture 96 in the vessel.

One or more of needles 18 and ferrules 44, 46 for use in the presentinvention can be provided as substantially described in U.S. Pat. No.6,136,010 issued to Modesitt et al. and/or U.S. Pat. No. 6,368,334issued to Sauer, which are incorporated herein by reference in theirentirety.

Proximal end 34 of needle 18 can be free and configured to be handled bya surgeon. Alternatively, proximal end 34 can be engageable or securedto a needle pusher 26 shown in FIG. 2. In yet another embodiment,proximal end 34 can be integral or formed as a single unit with needlepusher 26. In either embodiment, needle pusher 26 is sized to bepositioned within channel 24 and can further include a projection 36 toallow the surgeon to advance the needle pusher/needle combination alongchannel 24. In a preferred embodiment, needle pusher 26 is configuredsuch that the surgeon can sequentially advance needle 18 in a proximaldirection towards the patient and in a distal direction away from thepatient.

Referring back to FIG. 2, distal member 14 can also include a lumen 39extending at least partially therethrough. Preferably, lumen 39 isseparate from receptacle 22. Lumen 39 can be provided to receive orfollow a guide wire left in place after a particular diagnostic ortreatment procedure. This can allow the facile insertion of distalmember 14 into the patient's vascular vessel. In a preferred embodiment,an opening 40 receives a guide wire (not shown) that extends throughlumen 39 and exits through a side opening 41 of distal member 14 topermit the guide wire to extend out without interfering with theneedles, needle path, or suture material. The guide wire can be removedafter placement of the suture device or left in as desired or consideredmedically prudent by the surgeon.

Intermediate member 16 is located between proximal member 12 and distalmember 14. Intermediate member 16 defines a tissue-receiving area 45. Inthe illustrated embodiment, intermediate member is configured to includean arcuate portion or a crooked section. The arcuate portion or crookthus defines a concave interior surface 47 and a convex exterior surface48. Intermediate member 16 includes a first opening 50 providing accessfrom the channel 24 to the tissue receiving area 45 and a second opening52 from the receptacle 22 providing to the tissue receiving area 45.Preferably, first and second openings 50 and 52 are linearly or axiallyaligned. Intermediate member 16 can be composed of a biocompatiblematerial that is substantially resistant to deformation and thereforecan maintain the linearity between channel 24 and receptacle/chamber 22and the respective first and second openings 50 and 52. Examples ofsuitable materials include TEFLON, NYLON, polyamids, and the like.

Intermediate member 16 also includes means and structure for reliablepositioning of the device during surgery to facilitate closing thevascular puncture wound with sutures. Part of the positioning structureincludes an opening 54 providing fluid communication to blood returnlumen 25 in proximal member 12. In a preferred embodiment, opening 54 islocated on a portion of the convex surface of the crook opposite thetissue receiving area 45. When the distal member 14 of the device issuitably positioned within the lumen of a vascular vessel, opening 54 isalso located in the interior of the lumen. This permits blood from thevessel to enter blood return lumen 25, which can then be visiblyobserved by the surgeon. If blood is not observed in blood return lumen25, then the distal member may not have been inserted to a sufficientdepth into the lumen of the vascular vessel.

Additionally, a ridge or stop 56 extends from the concave surface intothe tissue receiving region. Stop 56 is configured to bear againstvascular tissue adjacent the puncture wound. In a preferred embodiment,first opening 50 is adjacent stop 56 permitting needle 18 to piercetissue adjacent thereto. Stop 56 is sized to bear against the vasculartissue and avert further insertion of the device 10 into the vascularvessel. When provided together, stop 56 and opening 50 with blood returnlumen 25 cooperate to ensure accurate placement of the suturing devicein the patient's vascular vessel. Ridge or stop 56 can also extendradially about the entire circumference of intermediate member 16.

FIG. 7 is a cross-sectional view of an intermediate member 70 of analternative embodiment of a suture device. In this embodiment, fittings72 and 73 are positioned radially or laterally displaced from each otherin receptacle 74. A first fitting 72 is positioned axially aligned withsecond opening 75 in the distal member 76. A biasing element such as aleaf spring 77 can also be positioned in receptacle 74 to urge secondfitting 73 into axial alignment with opening 75 once first fitting 72has been displaced. Biasing element 77 can be a leaf spring asillustrated, an elastomeric projection, or other known biasing materialsuitable to urge fitting 72 into alignment as desired. FIG. 8 is aperspective view of another embodiment of a suturing device 80 with aneedle cartridge in accordance with the present invention. Device 80includes a proximal member 81, a distal member 82, and an intermediatemember 83 therebetween. Proximal member 81 includes a needle cartridge84 slidably mounted in body 85. Needle cartridge 84 can include aplurality of needle slots, for example one, two, three, or more slots 86a. 86 b, 86 c . . . , each for a separate needle. Typically, the numberof needles in needle cartridge 84 will coincide with the number offittings with suture material in the receptacle in distal member 82.Each needle in needle cartridge 84 is individually advanceable through acentral needle channel 87 along a length of proximal member 81. Needlecartridge 84 is laterally displacable within body 85 to axially alignthe selected needle slot 86 a. 86 b, 86 c . . . with a single needlechannel. If desired, needle cartridge can be biased to automaticallyalign the successive needle slots with the needle channel after thepreceding needle has been advanced along the channel. Alternatively,suturing device 80, body 120, and/or cartridge 118 can include one ormore of ratchetings, positive stops, or locks to individually align thedesired needle slot with the channel. In other embodiments, needlecartridge 84 can be provided as a revolving barrel that can hold two,three, or more needles in respective needle slots radially disposedabout the barrel. The barrel can be rotatably mounted on or aboutproximal member 81. Distal member 82 and intermediate member 83 can beconfigured substantially as described above for members 14 and 16,respectively.

Referring to FIGS. 9 through 14, use of the suturing device 10, will nowbe described. A puncture wound in a vascular vessel can be suturedclosed using the suturing device 10. Suturing device 10 can be inserteddistally into the vascular vessel. This can be accomplished with orwithout the use of a guide wire. In a procedure where a guide wire hasbeen previously used, suturing device 10 can be threaded onto a guidewire 92 which extends from internal vessel lumen 94 through a puncturewound 96 in vessel 93 and through a portion of the overlying tissue 95to be exposed to the surgeon. In that regard, side opening 41 of lumen39 can be threaded onto guide wire 92 which then extends out throughopening 40. Thus, the flexible portion of distal member 14 can begingerly threaded into the lumen 94 of vessel 93. The distal member 14of device 10 can be positioned within lumen 94 such that intermediatemember 16 engages with a portion of the tissue surrounding puncture 96.Distal member 14 is advanced in a distal direction until blood isobserved in blood return lumen 25. Additionally, when provided, stop 56abuts or bears against the external surface of the vascular vessel. Thiscan be detected by the increased resistance to further advancement ofthe device in the distal direction. Both blood return lumen 25 and stop56 can be used to ascertain that the device has been correctlypositioned within the lumen 94 of the vascular vessel 93 to allowsuturing of puncture 96. It should be noted that observance of blood inneedle channel 24 is an indication that device 10 has been inserted toofar into the lumen such that first opening 50 is exposed to the interioror blood side of vessel 93. If desired, guide wire 92 can then bewithdrawn from lumen 39 and out of vascular vessel 93—if it is no longerneeded for subsequent procedures.

After the distal member 14 is positioned as desired, the vascular tissueadjacent the puncture wound is received within the tissue receiving area45. As noted above, intermediate member 16 provides an essentiallylinear needle pathway between channel 24, receptacle 22, and thevascular tissue in the tissue receiving area 45. Consequently, whenneedle 18 is advanced through channel 24, it pierces the vascular tissueat a first suture site 97 adjacent the puncture wound 96.

FIG. 10 illustrates suturing device 10 at a first suture position withneedle 18 a advancing distally through channel 24 and piercing thevascular tissue of vessel 93 at a first suture site 97 on a first sideof wound 96. From there, needle tip 32 advances into to receptacle 22 toengage in a first ferrule 44. Once engaged with ferrule 44, first needle18 a can then be withdrawn back through opening 52 in distal member 14and through first suture site 97, drawing a length of suture material 20through the vascular tissue in a proximal direction as illustrated inFIG. 11. Preferably the needle path in the proximal direction is thesame as in the distal direction—provided that the suturing device hasnot been moved or dislocated. Needle 18 a, including a length of suturematerial 20 can then be removed from suture device 10. Alternatively,needle 18 a and/or a length of suture material can be retained withsuture device 10 for subsequent retrieval and use in securing the woundclosure.

Thereafter, suture device 10 is rotated into a second suture position asillustrated in FIG. 12. For example, suture device 10 may be rotatedapproximately 180° so that in the second suture position, suture device10 is positioned to operate on a second side of puncture 96diametrically opposite first suture site 97. After ensuring that thesuturing device is correctly positioned, the procedure described abovefor needle 18 a can be followed. At the second suture position, a secondneedle 18 b is distally advanced using a needle pusher, either the sameneedle pusher or a second, different needle pusher, through channel 24to engage in and pierce the vascular tissue 93 received within tissuereceiving area 45 at second suture site 99. Again, needle 18 b isadvanced to enter receptacle 22 and there engage with second ferrule 46as shown in FIG. 13. Withdrawal of the needle pusher concomitantlywithdraws ferrule 46, and a length of suture 20 through second suturesite 99 as shown in FIG. 14. Needle 18 b and the attached ferrule 46 andlength of suture material can be retrieved by the surgeon either by handor received within a slot in the proximal member. Thereafter, ifdesired, the process can be repeated, rotating suturing device 10through about 90° and again, advancing a needle to engage in asubsequent ferrule located in receptacle 22. This process can berepeated as desired and as provided with a number of needles and/orsuture materials with ferrules in receptacle 22. It will be understoodthat in one embodiment, first and second lengths of suture materials aretwo ends of the same suture. In other embodiments, lengths of suturematerial are separate pieces of suture. Thereafter, device 10 can bewithdrawn from the body as illustrated in FIG. 15.

As illustrated in FIGS. 16 the lengths of suture material 20 can begathered. The length of suture material can be separated from theneedles. Pulling the lengths of suture material taut closes the wound 96in the vessel 93. In this embodiment, the path of the suture materialpasses through vascular tissue on a first side of the wound into thelumen 94 of the vessel 93, across the wound 96—again in the lumen 94—andthen out through the vascular tissue 93 on a second or opposite side ofthe wound. A surgical knot can be tied securing the wound closure. Aknot pusher, for example, the knot pushers described in U.S. Pat. No.5,304,184 issued to Hathaway et al., U.S. Pat. No. 5,746,755 issued toWood et al., and U.S. Pat. No. 6,132,439 issued to Kontos, can be usedto advance the loosely tied knot to the exterior surface of the vascularvessel. In selected embodiments, the surgeon can then tie a suitablesurgical knot using the respective lengths of suture material to closethe puncture wound 96. In other embodiments, the suture material can besecured using a variety of knot replacement technologies such as thatdisclosed in U.S. patent application Ser. No. 10/164,606 (U.S. PatentPublication No. 2003/0229377) and in Ser. No. 10/305,923 (U.S. PatentPublication No. 2004/0102809) and depicted in FIGS. 21 and 22. Each ofthe above-noted references are incorporated by reference in theirentirety.

FIG. 17 is a perspective view of one embodiment of a hollow needle 88for use in accordance with the present invention. Needle 88 includes adetachable tip 89, a hollow shaft 90, and a length of suture material91. The length of suture material 91 extends out the proximal end ofhollow needle 88. In one embodiment, one end of the suture material 91is attached to needle tip 89. In this embodiment, the needle tip 89 canbe used to pull suture material 91 through a portion of a suturingdevice or through vascular tissue as discussed more fully below. FIGS.18 through 20 illustrate the use of hollow needles with the suturingdevice 10. The suturing device 10 is inserted into the vascular vesselas described above and illustrated in FIG. 9. After suturing device 10has been positioned within the lumen 94 as desired, needle 88 isadvanced in the distal direction through needle channel 24 to piercevascular tissue 93 adjacent the wound 96 in the vessel and then intorecess 22 to engage with a first ferrule 44. Needle 88, the attachedferrule 44, and a length of suture material 20 are withdrawn in theproximal direction back through the needle path through a first suturesite.

Suturing device 10 can be rotated about its longitudinal axis whilemaintaining the distal member within the vascular lumen to a secondsuturing position. FIG. 19 illustrates the advancement of hollow needle88 along channel 24. Hollow needle 88 can pierce vascular tissue 93 at asecond suture site. Needle tip 89 can then engage with the secondferrule 46 located in receptacle 22. Once engaged to second ferrule 46,needle tip 89 can be separated from shaft 90 by withdrawal of the needleshaft 90 back through the second suture site. The needle shaft can bereceived in or through channel 24. Suture material 91 is then connectedto suture material 20 via ferrule 46 and needle tip 89. Suturing device10 can then be removed from the vascular vessel and eventually from thepatient.

Referring now FIG. 20, suture material 20 and 91 are connected togetherusing second ferrule 46 and needle tip 89. The connected suture materialcan be pulled in either direction by 1) pulling on suture material 20 inthe distal direction to draw ferrule 46, needle tip 89, and a portion ofsuture material 91 through the second suture site, or 2) pulling onsuture material 91 in the distal direction to draw ferrule 46, needletip 89, and a portion of suture material 20 through the second suturesite. In yet other embodiments, the free ends of suture material 20 and91 can be pulled taut to close the vascular wound. Preferably in thisembodiment both of needle tip 89 and ferrule 46 (as well as the suturematerials) are composed of a biodegradable material to biodegrade.Biodegradable materials for the ferrule, needle tips, and suturematerial are well known in the art and these materials are useful toprepare the components of the present invention.

FIG. 21 is a perspective view of a suture securing device 102 for use inthe present invention. Suture clamping device 102 is described andillustrated in U.S. Patent Publication No. 2004/0102809 which isincorporated herein by reference. In use, device 102 can secure ends ofone, two, three or more lengths of suture material. Two lengths ofsuture material 104 a and 104 b are illustrated with device 102. Thelengths of suture material are threaded into the flexible elements 105 aand 105 b which are then locked or fixed together clamping the suturematerial therein. FIG. 22 shows another embodiment of suture clampingdevices 106 a and 106 b for use in the present invention. Devices 106 aand 106 b are described in U.S. Patent Publication No. 2003/0229377which is incorporated herein by reference in its entirety. Devices 106 aand 106 b cooperate by separately clipping onto a selected length ofsuture material 104 a or 104 b which have previously pulled taut toclose the wound 96 or complete the surgical procedure. The devicesprevent the suture material from regressing back through the suturedtissue.

The present invention provides a variety of means, devices and methodsfor closing wounds in tissue and is particularly, but not exclusively,suitable for vascular tissue. It will be understood that the presentinvention contemplates modifications as would occur to those skilled inthe art without departing from the spirit of the present invention. Inaddition, where the various structures, elements, and procedural stepsor stages have been described with reference to a specified embodimentand device. Each of the individual or a combination of the structures,elements, and procedural steps or stages are contemplated to becombinable with each of the other embodiments and devices describedherein and as such are contemplated to be within the scope of thepresent invention.

Further, all publications, patents, and patent applications cited inthis specification are herein incorporated by reference as if eachindividual publication, patent, or patent application was specificallyand individually indicated to be incorporated by reference and set forthin its entirety herein. Further, any theory of operation, proof, orfinding stated herein is meant to further enhance understanding of thepresent invention and is not intended to make the scope of the presentinvention dependent upon such theory, proof, or finding.

1. A suturing device for suturing an opening in a vascular vessel, saiddevice comprising: a proximal member including an elongate body having aneedle channel therethrough sized to receive at least two hollowneedles; a distal member configured to be inserted within a lumen of avascular vessel, said member having a receptacle, wherein the receptacleis elongate, located therein; an intermediate member disposed betweenthe proximal member and the distal member, said intermediate memberdefining a tissue receiving area and having a first opening providing apassageway to the needle channel and a second opening providing apassageway into the receptacle; a length of suture material having twoneedle engaging fittings, each of the two needle engaging fittings beingpositioned in the receptacle to engage at least one of the at least twohollow needles entering from the second opening, one of the two needleengaging fittings being disposed proximal to the other needle engagingfitting within the receptacle, wherein the two needle engaging fittingsin the receptacle have differing cross-sectional diameters and areaxially displaced from each other, a distal-most needle engaging fittingbeing smaller in cross-sectional diameter than a proximal-most needleengaging fitting, the receptacle in said distal member is beingsubstantially in line with the longitudinal axis of said needle channeland the intermediate member deviates from the longitudinal axis.
 2. Thedevice of claim 1 wherein the needle engaging fitting comprises ferrulehaving a needle engaging tab.
 3. The device of claim 2 wherein theferrule comprises a cylindrical housing having a plurality of tabsextending radially into the cylindrical housing.
 4. The device of claim2 wherein each of the at least two hollow needles comprises a recessedengaging surface configured to engage with the needle engaging tab. 5.The device of claim 1 wherein the length of suture material comprises afirst needle engaging fitting on a first end and a second needleengaging fitting on a second end.
 6. The device of claim 1 wherein thereceptacle is substantially circular or oval in cross section and thetwo needle engaging fittings are radially displaced from each other. 7.The device of claim 1 wherein the proximal member contains a singleneedle channel extending therethrough.
 8. The device of claim 1 whereinsaid receptacle has an abutment to limit the distal movement of saidneedle engaging fitting.
 9. The device of claim 1 wherein the proximalmember comprises a needle cartridge having a plurality of slotsconfigured to slidably receive the at least two hollow needles.
 10. Thedevice of claim 9 wherein the cartridge is slidably mounted on theproximal member to sequentially align one of the slots with the needlechannel.
 11. The device of claim 1 further comprising a needle pusherslidably mounted in alignment with the needle channel to advance the atleast two hollow needles along the channel in a direction toward thefirst opening in the connecting member.
 12. The device of claim 1wherein the at least two hollow needles further comprise a length ofsuture material extending at least partly therethrough.
 13. The deviceof claim 1 wherein the connecting member is curved or angled to define atissue receiving recess configured to receive a portion of vasculartissue adjacent the opening in the vascular vessel.
 14. The device ofclaim 1 wherein at least a portion of the distal member is flexible. 15.The device of claim 1 wherein the connecting member is rigid.
 16. Asuturing device for suturing an opening in a vascular vessel, saiddevice comprising: a proximal member including an elongate body having aneedle channel therethrough sized to receive at least one hollow needleand including a needle cartridge slidably mounted thereon configured tocontain a plurality of hollow needles; a distal member configured to beinserted within a lumen of a vascular vessel, said member having areceptacle located therein; an intermediate member disposed between theproximal member and the distal member, said intermediate member defininga tissue receiving area and having a first opening providing apassageway to the channel and a second opening providing a passagewayinto the receptacle; a length of suture material having two needleengaging fittings, each of the two needle engaging fittings beingpositioned in the receptacle to engage the at least one hollow needle ofthe plurality of hollow needles entering from the second opening, afirst needle engaging fitting of the two needle engaging fittings beingdisposed proximal to the other needle engaging fitting within thereceptacle, the first needle engaging fitting having a cross-sectionaldiameter greater than that of the other needle engaging fitting.
 17. Thedevice of claim 16 wherein each needle engaging fitting comprises aferrule having a needle engaging tab.
 18. The device of claim 17 whereinthe ferrule comprises a cylindrical housing having a plurality of tabsextending radially inward.
 19. The device of claim 16 wherein the atleast one hollow needle comprises a recessed engaging surface configuredto engage with the needle engaging tabs.
 20. The device of claim 16wherein the proximal member contains a single needle channel extendingtherethrough.
 21. The device of claim 16 wherein the connecting memberis curved or angled to define a tissue receiving recess configured toreceive a portion of vascular tissue adjacent the opening in thevascular vessel.
 22. The device of claim 16 comprising a needle pusherslidably mounted in alignment with the needle channel to advance the atleast one hollow needle of the plurality of needles along the needlechannel in a direction toward the first opening in the connectingmember.